Expandable introducer sheath

ABSTRACT

The invention relates to an introducer sheath for catheters to be inserted into a vascular system comprising a connecting valve (2) and an insertion tube (3) having a proximal portion (4) and a distal portion (5), said distal portion (5) being of reduced diameter in comparison with the proxirmal portion (4), and to enable its diameter to be reversibly changed the insertion tube (3) is provided with longitudinally extending expansion elements with incisions (11, 11′, 12) designed to as predetermined breaking points.

The invention relates to an introducer sheath for catheters forinsertion into a vascular system, said sheath comprising a connectingvalve and an insertion tube having a proximal portion and a distalportion, said distal portion being of reduced diameter in comparisonwith the proximal portion.

Introducer sheaths are known that enable the vascular system to beaccessed. They are needed if for an endovascular treatment a catheterhas to be inserted into a vessel system via which implants or medicalinstruments are brought into the vascular system. Such introducersheaths consist as a rule of plastic material, for example ofpolytetrafluoroethylene or other fluorinated polyolefins. In addition toproviding access for a catheter introducer sheaths of this kind may alsopossess further means of entry that, for example, can be used for theintroduction or aspiration of fluids.

It is frequently necessary during endovascular treatment to successivelyintroduce into the vessel various medical devices of different size ordiameter. Normally, introducing microcatheters by means of a guidewireis considered unproblematic; however, problems are encountered in theevent of catheters of larger caliber as they are needed, for instance,for vessel dilatation, for the extraction of clots or for theimplantation of large-caliber stents.

On the one hand, large-caliber introducer sheaths or insertion aids aredifficult to navigate and, on the other, they often lead to injuries ofthe vessel wall and the tissue in the insertion zone when being removed.It has turned out to be of advantage to make use of introducer sheathsthe inner diameter of which can be adapted to the relevant task orpurpose, i.e. sheaths that are also suitable to accommodate catheters oflarge caliber and, moreover, that are capable of adjusting themselves tosuch large-size catheters. Nevertheless, problems may arise in the eventthe introducer sheaths having expanded to suit the required diametermaintain this expanded diameter even after the catheter has beenremoved.

It would thus be desirable for this reason to have available anintroducer sheath capable of adjusting itself to the relevant cathetersize needed in a given case but with said sheath reducing to thediameter originally arranged for after the catheter has been removed.After the treatment has been completed such an introducer sheath can beretracted quite easily and with only minimum risks of causing injuriesto the vascular system.

This objective is reached by providing an introducer sheath of the kindfirst mentioned above, said sheath having an insertion tube enabling itsdiameter to be reversibly changed and having longitudinally extendingexpansion elements in which incisions are arranged designed aspredetermined breaking points.

The introducer sheath proposed by the present invention for catheters tobe placed into vascular systems is provided with a common connectingvalve and an insertion tube. In the area of the connecting valve one orseveral additional accesses may be arranged which are preferablysafeguarded by means of a Luer lock.

The insertion tube is divided into a proximal portion and a distalportion, with the diameter of the proximal portion being larger thanthat of the distal portion. The diameter of the distal portion enablescustomary small-caliber catheters to pass through. When placed inposition the proximal portion of the introducer sheath is located in theaccess zone whereas the distal portion of the introducer sheath designedto offer the required flexibility is situated fully or for the main partin the vascular system. To facilitate the placement process thetransitional zone between the proximal and the distal portion of theintroducer sheath is of tapered design.

To enable large-caliber catheters to be introduced after havingcompleted placement of the introducer sheath and insertion of aguidewire into the vascular system a plurality of longitudinallyextending incisions are provided in the insertion tube, said incisionsserving to reversibly change the tube diameter. Said incisions aredesigned such that they are capable of adjusting to a catheter of largercaliber and after the catheter has been removed cause the tube to reduceto its original diameter. In expanded state, the diameter of theinsertion tube may increase by 200% or more with respect to its reducedstate.

The incisions are so designed that they tear open when a catheter oflarger caliber is being inserted, i.e. they are designed to serve aspredetermined breaking points. To this end, the incisions preferablypenetrate into the wall thickness of the 1 o insertion tube down toapprox. 25 to 95%. The incisions may be arranged on the inside oroutside; however, arranging them on the outside is preferred. Usually,an incision depth of between approx. 60 and 90% of the wall thickness isconsidered sufficient.

Especially in its distal portion, the introducer sheath proposed by thepresent invention is provided with expansion elements. In any case, theexpansion elements are also arranged over the preferably taperedtransition area located between the proximal and distal portion. In thiscase, the expansion elements are equally spaced over the circumferenceof the insertion tube.

As per an embodiment of the invention the expansion elements areprovided in the form of incisions which, however, do not extend over theentire length of the distal portion of the insertion tube.

In particular, the insertion tube is provided with two types ofincisions of which first incisions extend from proximal to distal andterminate before the distal end of the insertion tube whereas secondincisions which run from the distal end towards proximal extendingmerely over a distal area of the insertion tube. The second incisionsmay be provided in the form of slots fully penetrating through the wall.

In this manner, the distal portion of the introducer sheath is dividedin a proximal area and a distal area, wherein the distal area denotesthe zone through which the second incisions extend while the proximalarea is to be understood as the zone proximally connecting to theproximal portion of the insertion tube. To the extent they also extendwithin the distal area the first incisions are preferably provided aswell in the form of slots.

The first and second incisions are alternately arranged in the distalarea of the insertion tube. This arrangement enables the second slots inthe distal area of the insertion tube to form in expanded state acircumferential crown of meandering webs similar to the meanderingstructure of webs in a stent when expanded.

It is considered expedient to arrange an opening in the first incisionsapproximately at a location where the second incisions terminate, i.e.where the distal area of the insertion tube begins, said opening havinga shape that roughly resembles an elongated diamond. This opening servesthe purpose of facilitating the expansion of the insertion tube.

In accordance with another variant of the invention the expansionelements are incisions provided in the insertion tube surface, saidincision extending in longitudinal direction alternately on the insideand outside. In this case, the depth of the incisions ranges between 50and 80% of the wall thickness of the insertion tube, preferably betweenapprox. 65 and 75%. Incisions of this configuration enable anaccordionlike widening of the insertion tube when a large-calibercatheter is pushed through the tube. The amount by which the tube widensdepends on the wall thickness, the depth of the incisions and thespacing of the incisions.

Incisions of this kind may extend over the entire length of the distalportion of the insertion tube. However, as provided for by analternative, the incisions may only be arranged in the proximal area ofthe insertion tube while in the distal area the arrangement of slots asdescribed hereinbefore is used according to which the slots in expandedstate of the insertion tube form a circumferential crown of meanderingwebs. The number of incisions made in the proximal area of the insertiontube may in this case be considerably higher than the number of slotsarranged in the distal area.

As per another variant of the invention the incisions of the expansionelements are provided in the form of slots also in the proximal area ofthe insertion tube, said slots fully cutting through the wall of theinsertion tube. In this case as well the insertion tube canappropriately widen in the event a large-caliber catheter is introduced.When applying this variant it is to be noted, however, that wheninserting the introducer sheath into the vascular system adequatesealing measures must be taken during the insertion phase since theseslots are not capable of sealing the system effectively.

The invention is explained in more detail by way of the enclosed figureswhere

FIG. 1: shows an inventive introducer sheath in non-expanded state;

FIG. 2: depicts the introducer sheath shown in FIG. 1 in expanded state;

FIG. 3: illustrates the distal area of the insertion tube innon-expanded state;

FIG. 4: shows the distal area of the insertion tube in expanded state;

FIG. 5: shows the insertion tube in expanded state with a catheterinserted.

FIG. 1 illustrates an introducer sheath 1 proposed by the invention withthe connecting valve 2 and insertion tube 3. The insertion tube 3 itselfis divided into a proximal portion 4 with fixed diameter and a distalportion 5 which is of variable diameter as a result of the arrangedexpansion elements. Moreover, the distal portion 5 of the insertion tube3 is divided into a distal area 7 and proximal area 7′ located above andadjacent to the proximal portion 4. In this way, the proximal and distalareas of the insertion tube are complementary in forming distal portion5.

In the distal portion of the insertion tube there are longitudinallyextending incisions 11 together with webs 8. Incisions 11 are equallydistributed over the circumference of the insertion tube 3. Incisions 11are also arranged in the transitional zone 6 which has a tapered shape.In the transitional area 6 which is considered to form part of distalportion 5 the inner and outer diameter of the proximal portion 4 reducesto that of the distal area 5.

Incisions 11 represent the first incisions extending from the proximalend of the distal portion 5 to just before the distal end of the distalportion 5. In the distal area 7 the incisions 11 are preferably designedin the form of slots 11′. In the distal area 7 between the firstincisions 11 and 11′ there are second incisions 12 which are alsodesigned in the form of slots, they are also regularly spaced and extendfrom the distal end 10 over the entire distal area 7. The alternatingarrangement of the first and second incisions in distal area 7 allowsthe formation of a crown of meandering webs that occupies the entiredistal area 7. At the distal end 10 of the insertion tube 3 the webs arerounded so as to be atraumatic.

The expanded state of introducer sheath 1 in accordance with FIG. 1 isillustrated in FIG. 2. The incisions 11, 11′, and 12 located betweenwebs 8 and 9 are expanded and extend to shortly before the distal end 10of insertion tube 3. In the distal area 7 of insertion tube 3 the webstructure widens to form a meandering crown of webs, with the individualwebs located between the second incisions 12 being of vee-shapedconfiguration. In the transitional area 6 of insertion tube 3 theexpanded incisions 11 taper off until the normal diameter of theproximal portion 4 is reached.

Whereas incisions 11 in non-expanded state as illustrated in FIG. 1 donot yet fully cut through the tube wall in the proximal area 7′ theincisions 11 in expanded state as shown in FIG. 2 are forced open andwidened to form elongated interspaces. The incisions 11 are torn openwhen a large-caliber catheter is introduced. In the distal area 7 theslots 11′ and 12 widen to form the vee-shaped interspaces locatedbetween webs 9 that constitute the crown of webs.

FIG. 3 is a detailed view of the insertion tube 3 showing distal area 7and part of proximal area 7′ arranged proximally adjacent to it, alsoincisions 11, 11′, and 12 and the longitudinally extending webs 8 aswell as webs 9 that when expanded form into a meandering configuration.The illustration shows the approximately diamond-shaped openings offirst incisions 11 located in the transitional area towards distal area7 as well as the rounded webs at the distal end 10 of insertion tube 3.It is to be noted that incisions 11′ and 12 are designed as slots thatfully cut through the wall.

FIG. 4 shows a detail of FIG. 3 in expanded state with the meanderingcrown of webs in distal area 5 and the parallelly extending webs locatedin the proximally adjacent area. The incisions 11, 11′, and 12 areenlarged to form relatively wide interspaces.

In conclusion, FIG. 5 shows the expanded section of the insertion tubedepicted in FIG. 4 with introduced catheter K that has caused expansionto take effect.

Retraction of the catheter upon completion of the respective treatmentcauses the insertion tube to be relieved of the expansion pressure sothat it is able to contract and again assume its original diameter. As aresult of this, the insertion tube can be drawn out and removed quiteeasily of its position in the tissue without the risk of causing tearsor scissures in tissue and vessel wall.

1. Introducer sheath for catheters to be inserted into a vascularsystem, said sheath comprising a connecting valve (2) and an insertiontube (3) having a proximal portion (4) and a distal portion (5), saiddistal portion (5) being of reduced diameter in comparison with theproximal portion (4), wherein the insertion tube (3), in order to enableits diameter to be reversibly changed, is provided with (i)longitudinally extending first expansion elements with first incisions(11, 11′) designed as predetermined breaking points, said firstincisions extending from the proximal end of the distal portion (5) to aposition adjacent to the distal end of the distal portion (5); (ii)longitudinally extending second expansion elements with second incisions(12), said second incisions originating from the distal end (10) of theinsertion tube (3) and extending in a distal area (7) of said tube. 2.Introducer sheath according to claim 1, characterized in that theincisions (11, 11′, 12) are equally spaced over the circumference of theinsertion tube (3).
 3. Introducer sheath according to claim 1,characterized in that the incisions (11, 11′, 12) are designed, at leastpartially, in the form of slots.
 4. Introducer sheath according to claim3, characterized by first incisions (11, 11′) and second incisions (12)in the distal portion (5) of the insertion tube (3), of which the firstincisions (11, 11′) extend from proximal to distal and the secondincisions (12) run from the distal end towards proximal, wherein theareas located between the first (11, 11′) and the second incisions (12)constitute webs (8, 9) of equal width.
 5. Introducer sheath according toclaim 4, characterized in that the first incisions (11′) and secondincisions (12) are alternately arranged in a distal area (7) of theinsertion tube (3).
 6. Introducer sheath according to claim 5,characterized in that the second incisions (12) in expanded state of theinsertion tube (3) form a circumferentially extending crown ofmeandering webs (8) in the distal area (7).
 7. Introducer sheathaccording to claim 5, characterized in that the first incisions (11) ata transition zone from the proximal (7′) to the distal (7) area areprovided with openings in the wall of the insertion tube (3). 8.Introducer sheath according to claim 1, characterized in that theexpansion elements are incisions (11, 11′) that are alternately arrangedon the inside and outside of the insertion tube (3).
 9. Introducersheath according to claim 8, characterized in that the depth of theincisions ranges between 25 and 95%, preferably 60 and 90% of the wallthickness of the insertion tube (3).
 10. Introducer sheath according toclaim 8, characterized in that the incisions extend over the proximal(7′) of the insertion tube (3).
 11. Introducer sheath according to claim10, characterized by first and second incisions (11′, 12) in the distalarea (7) of the insertion tube (3), said incisions forming webs (9)having a meandering configuration.
 12. (canceled)
 13. (canceled) 14.(canceled)